Regulatory and Clinical Affairs Manager

Stryker Corporation; Portage (MI); Hybrid; Confidential; Full time

Job summary

Stryker Corporation is seeking a Manager of Regulatory and Clinical Affairs for its Acute Care segment in Portage, Michigan. This role offers remote or hybrid work arrangements and leads a高performing team to shape regulatory strategies, clinical evidence, and lifecycle activities across global markets.

You will oversee submissions, maintain compliance, and collaborate with QA, R&D, sales, and manufacturing to align goals and budgets.

Qualifications

• Bachelor’s degree in science, engineering, life sciences, biology, biomedical engineering, nursing, or a related discipline required; advanced or master’s degree preferred.
• Minimum of 8 years of regulatory and/or clinical affairs experience in the medical device industry.
• Minimum of 2 years of management experience, and/or demonstrated high-performance leading critical projects or teams.

Responsibilities

• Provide leadership for Regulatory Affairs and Clinical Affairs activities, establishing strategies, processes, goals, and metrics.
• Lead regulatory and clinical team members to deliver projects with quality and timeliness.
• Drive regulatory strategy, market access, clinical evidence generation, and deliverables for devices.
• Manage day-to-day regulatory and clinical processes, escalation, and communications.
• Lead teams supporting regulatory submissions, registrations, renewals, and clinical projects.

Skills

Regulatory affairs

Clinical affairs

Leadership

Cross-functional collaboration

Project management

Communication

Stakeholder management

Team leadership

Education

Bachelor’s degree

Advanced degree preferred

Job description

Work Flexibility: Remote or Hybrid or Onsite

We are currently seeking a Manager, Regulatory and Clinical Affairs to join our Acute Care business unit. Join us at the intersection of innovation, science, and patient care. As Manager, Regulatory and Clinical Affairs, you will play a pivotal role in shaping the regulatory and clinical strategies that enable products to reach markets globally and improve patient outcomes. You will lead a high-performing team, collaborate with cross-functional partners across the organization, and influence decisions that drive business success while ensuring compliance and patient safety. This role is Remote or Hybrid in Portage, Michigan.

What you will do

• Provide leadership for Regulatory Affairs and Clinical Affairs activities, establishing strategies, processes, goals, and metrics that drive measurable improvement and support business objectives.
• Lead regulatory and clinical team members to deliver projects and activities with appropriate quality and timeliness, including oversight of priorities, timelines, deliverables, execution, and resource needs.
• Drive integrated approaches to regulatory strategy, market access, clinical evidence generation, and the development, review, and oversight of regulatory and clinical deliverables for new and existing medical devices.
• Manage day-to-day regulatory and clinical processes, ensuring issues are appropriately evaluated, escalated, resolved, and communicated.
• Lead teams supporting regulatory submissions, registrations, renewals, clinical projects, and clinical evidence activities across the product lifecycle.
• Provide direction on the interrelationship between regulatory strategy and clinical evidence, including recommendations and implementation plans for new or changing requirements and expectations.
• Collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, Sales, Marketing, and other partners to ensure corporate goals and strategies are met.
• Establish annual budgets and quarterly forecasts for the function and manage priorities and resources accordingly.
• Establish and improve standard processes, systems, and controls to ensure clear ownership, effective management, and continuous improvement of regulatory and clinical activities.
• Chair meetings needed to drive closure of regulatory and clinical issues and decisions.
• Manage and provide updates on regulatory and clinical metrics, trends, risks, and performance.
• Represent regulatory and clinical processes during internal and external audits and inspections.
• Define targets, KPIs, and performance objectives for individuals within the function and manage direct reports to meet or exceed expectations.
• Recruit, select, and onboard top talent; coach and develop team members; address performance issues; and maintain a high level of team engagement.
• Participate in advocacy and other activities of an advanced technical, tactical, audit, or strategic nature.

What you need

• Bachelor’s degree in science, engineering, life sciences, biology, biomedical engineering, nursing, or a related discipline required; advanced or master’s degree preferred.
• Minimum of 8 years of relevant experience including regulatory affairs and/or clinical affairs experience in the medical device industry.
• Minimum of 2 years of management experience required, and/or demonstrated high-performance leading critical projects or teams.
• Demonstrated ability to apply regulatory and clinical knowledge to cross-functional and interdivisional projects.
• Preferred experience planning or conducting clinical studies, including Investigational Device Exemption (IDE) and post-marketing clinical studies, strongly preferred.
• Demonstrated ability to integrate regulatory strategy and clinical evidence needs to support product development, submissions, market access, and lifecycle activities.
• Strong written, verbal, listening, communication, team building, and stakeholder-management skills.
• Demonstrated ability to collaborate effectively with and lead cross-functional teams and external stakeholders.
• Demonstrated ability to prioritize and manage multiple project workloads.
• Demonstrated experience with trending, analysis, metrics, and reporting.
• Demonstrated leadership, decision-making, process-improvement, and change-management skills.
• Experience with recruiting, onboarding, coaching, and people development.
• Ability to influence across the organization and communicate recommendations to management and cross-functional stakeholders.

Pay Ranges (US)

USN: $126,500 - $210,700 USD Annual. View the U.S. work location and transparency guide to find the pay range for your location.

Travel Percentage: 10%

Equal Opportunity Employment

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability. Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World's Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility Details

Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location.

Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based.

Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category.

Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.